Plos Med:卡非佐米+来那度胺+地塞米松和环磷酰胺用作多发性骨髓瘤移植前诱导化疗的效果和安全性

2021-01-13 MedSci原创 MedSci原创

卡非佐米是第二代不可逆性蛋白酶体抑制剂,治疗骨髓瘤有效,与第一代蛋白酶体抑制剂相比,发生周围神经病变的风险较小,更易于联合治疗。

卡非佐米是第二代不可逆性蛋白酶体抑制剂,治疗骨髓瘤有效,与第一代蛋白酶体抑制剂相比,发生周围神经病变的风险较小,更易于联合治疗。

骨髓瘤XI+试验,于2013年12月5日-2016年4月20日期间从英国的88个地点招募年满18岁的、可进行骨髓移植的、新诊断的、有症状的多发性骨髓瘤患者。受试患者被随机分配到两组,接受卡非佐米、来那度胺、地塞米松和环磷酰胺(KRdc)联合治疗(实验组),或来那度胺、地塞米松和环磷酰胺(Rdc)或沙利度胺、地塞米松和环磷酰胺(Tdc)联合治疗(对照组)。所有患者都计划在来那度胺维持治疗之前接受自体干细胞移植(ASCT)。共同主要终点是无进展生存期(PFS)和总生存期(OS)。预计中期分析报告PFS、缓解率和安全预后。

共招募了1056名患者(中位年龄61岁,范围33-75岁,39.1%的女性):KRDC组 526名,对照组(Tdc/Rdc)530名。中位随访34.5个月后,与Tdc/Rdc对照组相比,KRdc组的PFS显著延长(危险比0.63,95%CI 0.51-0.76)。接受KRdc治疗的患者的中位PFS尚无法评估,而Tdc/Rdc对照组的为36.2月(p<0.001)。PFS改善情况在包括遗传高危疾病患者在内的各亚组中保持一致。

诱导结束时,KRdc组至少获得非常好的部分缓解的患者比例为82.3%,而对照组为58.9%(优势比4.35,95%CI 3.19~5.94,p<0.001);KRdc组还有55%的患者达到了最小残留病灶阴性(骨髓白细胞阈值4×10-5),且在ASCT后,这一比例上升到了75%。

最常见的不良事件是血液毒性,心脏事件的发生率很低。该试验将继续随访患者至主要终点OS,并计划进行长期随访分析。

总之,与基于免疫调节剂的三联疗法相比,KRdc联合用药耐受性良好,且获得至少非常好的部分缓解的患者比例增加,PFS受益显著

原始出处:

Graham H. Jackson, et al. Carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide (KRdc) as induction therapy for transplant-eligible, newly diagnosed multiple myeloma patients (Myeloma XI+): Interim analysis of an open-label randomised controlled trial. Plos Med. January 11, 2021. https://doi.org/10.1371/journal.pmed.1003454

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    2021-02-09 jml2009
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    2021-01-13 ms5000000518166734

    已读,受益匪浅

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1890204, encodeId=9abf1890204bc, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Tue Feb 09 07:52:24 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1284371, encodeId=27a212843e1bb, content=<a href='/topic/show?id=73216852458' target=_blank style='color:#2F92EE;'>#环磷酰胺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68524, encryptionId=73216852458, topicName=环磷酰胺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=07f7192, createdName=waiwai3030, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555662, encodeId=b1ba15556622b, content=<a href='/topic/show?id=fe2f918e29b' target=_blank style='color:#2F92EE;'>#诱导化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91872, encryptionId=fe2f918e29b, topicName=诱导化疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610856, encodeId=64fc161085628, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916410, encodeId=118891641093, content=<a href='/topic/show?id=dd85431162e' target=_blank style='color:#2F92EE;'>#多发性骨髓瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43116, encryptionId=dd85431162e, topicName=多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 14 00:27:28 CST 2021, time=2021-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916381, encodeId=8d13916381a9, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Wed Jan 13 23:17:00 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916280, encodeId=ccb99162804a, content=最常见的不良事件是血液毒性,心脏事件的发生率很低。该试验将继续随访患者至主要终点OS,并计划进行长期随访分析, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Wed Jan 13 16:42:27 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047262, encodeId=cc63104e26288, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Jan 13 13:52:24 CST 2021, time=2021-01-13, status=1, ipAttribution=)]
    2021-01-13 Jessie Zhang

    最常见的不良事件是血液毒性,心脏事件的发生率很低。该试验将继续随访患者至主要终点OS,并计划进行长期随访分析

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1890204, encodeId=9abf1890204bc, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Tue Feb 09 07:52:24 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1284371, encodeId=27a212843e1bb, content=<a href='/topic/show?id=73216852458' target=_blank style='color:#2F92EE;'>#环磷酰胺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68524, encryptionId=73216852458, topicName=环磷酰胺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=07f7192, createdName=waiwai3030, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555662, encodeId=b1ba15556622b, content=<a href='/topic/show?id=fe2f918e29b' target=_blank style='color:#2F92EE;'>#诱导化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91872, encryptionId=fe2f918e29b, topicName=诱导化疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610856, encodeId=64fc161085628, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Fri Jan 15 01:52:24 CST 2021, time=2021-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916410, encodeId=118891641093, content=<a href='/topic/show?id=dd85431162e' target=_blank style='color:#2F92EE;'>#多发性骨髓瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=1, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43116, encryptionId=dd85431162e, topicName=多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Thu Jan 14 00:27:28 CST 2021, time=2021-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916381, encodeId=8d13916381a9, content=已读,受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f03a5433387, createdName=ms5000000518166734, createdTime=Wed Jan 13 23:17:00 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=916280, encodeId=ccb99162804a, content=最常见的不良事件是血液毒性,心脏事件的发生率很低。该试验将继续随访患者至主要终点OS,并计划进行长期随访分析, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Wed Jan 13 16:42:27 CST 2021, time=2021-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1047262, encodeId=cc63104e26288, content=疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=CHANGE, createdTime=Wed Jan 13 13:52:24 CST 2021, time=2021-01-13, status=1, ipAttribution=)]
    2021-01-13 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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